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TORCH-E2 is a prospective, multicentre, randomized phase II trial. 134 low-lying early (T1-3b/N0-1M0, distance from anal verge ≤5cm) patients will be recruited and assigned to Group 1 and Group 2 (1:1). Group 1 receives SCRT (25Gy/5Fx) followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody. Group 2 receives LCRT (50Gy/25Fx) followed by 2 cycles of CAPOX. A WW option can be applied to patients achieving cCR while surgery will be recommended for those who fail to achieve cCR. The primary endpoint is complete response (CR, pathological complete response [pCR] plus cCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, anal preservation rate, 3-year DFS rate, etc.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short-course Radiotherapy plus immunochemotherapy group | Experimental | The patients will receive short-course radiotherapy (25Gy/5Fx, SCRT), followed by 4 cycles of CAPOX and PD-1 antibody, finally receive the TEM or TME surgery or adopt WW option. |
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| Long-course Radiotherapy plus chemotherapy group | Experimental | The patients will receive long-course radiotherapy (50Gy/25Fx,LCRT, concurrent capecitabine), followed by 2 cycles of CAPOX, finally receive the TEM or TME surgery or adopt WW option. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Short-course radiotherapy | Radiation | Short-course radiotherapy: 25Gy/5Fx |
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| Measure | Description | Time Frame |
|---|---|---|
| complete response (CR) rate | Rate of complete response (CR), including the rate of pathologic complete response (pCR) after surgery and the rate of cCR with W&W strategy. | 1 month after the surgery or the decision of W&W |
| Measure | Description | Time Frame |
|---|---|---|
| Grade 3-4 adverse effects rate | Rate of chemotherapy, radiotherapy and immunotherapy related adverse events | From date of randomization until 3 months after the completion neoadjuvant therapy |
| Organ preservation rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhen Zhang, M.D, PH.D | Contact | 18801735029 | 18801735029 | zhen_zhang@fudan.edu.cn |
| Yajie Chen, PH.D | Contact | 18917239680 | 16111230008@fudan.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zhen Zhang, M.D, PH.D | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | China |
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| PD-1 antibody (Toripalimab) | Drug | Toripalimab 240mg d1 q3w |
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| Long-course radiotherapy | Radiation | Long-course radiation: 50Gy/25Fx |
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| Oxaliplatin | Drug | Oxaliplatin: 130mg/m2 d1 q3w |
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| Capecitabine | Drug | Xeloda |
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Organ preservation rate
| from date of receiving neoadjuvant therapy, assessed up to 3 years |
| 3 year disease free survival rate | Rate of 3 year disease free survival | From date of initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months. |
| 3 year local recurrence free survival rate | Rate of 3 year local recurrence free survival | From date of initiation of treatment until the date of first documented pelvic failure, assessed up to 36 months. |
| 3 year overall survival rate | Rate of 3 year overall survival | From date of initiation of treatment until the date of death from any cause, assessed up to 36 months. |
| 3 year Quality of Life | Quality of life will be evaluated using EORTC QLQ-C30, EORTC QLQ-CR29, LARS score and Wexner score. | From date of initiation of treatment until the date of death from any cause, assessed up to 3 years |
| ID | Term |
|---|---|
| C000656314 | toripalimab |
| D000077150 | Oxaliplatin |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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